Public consultation is one of the phases provided by the law that rules the health technology incorporation process in Brazilian Public Health System (SUS). In the Brazilian model, anyone can participate as long as he/she identifies her/himself. During the decision-making process these suggestions are analyzed by the National Committee for Health Technology Incorporation (CONITEC) and, sometimes, they are responsible for changing a preliminary recommendation for a technology. This study aims to identify the health technologies for which CONITEC revised the initial negative recommendations due to the contributions received during the public consultation.

A descriptive study using as input data the information on coverage decisions available on the CONITEC website.

Since CONITEC's creation until October 2017, CONITEC enacted 241 public consultations. Fifteen cases of change to the preliminary negative recommendation were found and among these eight (53 percent) had the economic studies or proposed technology price reconsidered by the companies. In the other seven decisions, the Board also regarded as important the reasons for changing the initial recommendation: new evidence on efficacy and safety as well as the analysis of different outcomes previously unconsidered in the preliminary assessment.

During the public consultations, besides technical-scientific information, personal experiences and opinion reports on each health technology analyzed, CONITEC received new price offers and economic studies from the applicants. This new material has allowed, in some cases, these technologies to become competitive and to be included as alternatives to those already available, provided there is no clinical impairment. This study reinforces the importance of the public consultation and social participation in the process of health technologies incorporation in Brazil, considering its capacity to add new information to the decision-making process.

Cardiac surgery has seen substantial scientific progress over recent decades. Health economic evaluations have become important tools for decision makers to prioritize scarce health resources. The present study aimed to identify and critically appraise the reporting quality of health economic evaluations conducted in the field of cardiac surgery.

A literature search was performed to identify health economic evaluations in cardiac surgery. The consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement was used to assess the quality of reporting of studies.

A total 4,705 articles published between 1981 and 2016 were identified; sixty-nine studies fulfilled the inclusion criteria. There was a trend toward a greater number of publications and reporting quality over time. Six (8.7 percent) studies were conducted between 1981 and 1990, nine (13 percent) between 1991 and 2000, twenty-four (34.8 percent) between 2001 and 2010, and thirty (43.5 percent) after 2011. The mean CHEERS score of all articles was 16.7/24; for those published between 1980 and 1990 the mean (SD) score was 10.2 (±1.4), for those published between 1991 and 2000 it was 11.2 (±2.4), between 2001 and 2010 it was 15.3 (±4.8), and after 2011 it was 19.9 (±2.9). The quality of reporting was still insufficient for several studies after 2000, especially concerning items “characterizing heterogeneity,” “assumptions,” and “choice of model.”

The present study suggests that, even if the quantity and the quality of health economics evaluation in cardiac surgery has increased, there remains a need for improvement in several reporting criteria to ensure greater transparency.

Telemedicine uses information and communication technologies to provide services in the field where the distance is a critical factor. The aim of the present study is to describe the experience of a synchronous telemedicine between two hospitals in Spain and Angola.

This is a retrospective observational study of all synchronous telemedicine sessions conducted between the Hospital Nossa Senhora da Paz in Angola and the Vall d'Hebron University Hospital in Spain from January 2011 to December 2014.

Seventy-two cases were discussed in the telemedicine sessions. The average age of patients was 18.02 (SD 13.75) years and mostly women (54.38 percent). Reasons to discuss the cases were 46.47 percent doubts in the diagnosis and therapeutic management, 15.47 percent were purely formative cases, and only 8.45 percent treatment doubt. At the time of presentation, 29 percent of the patients were already diagnosed, 95 percent of whom with infectious disease diagnostic, and from the undiagnosed patients 36 percent presented a febrile syndrome.

This study shows the viability of synchronous telemedicine between European and African countries without an excessively sophisticated technology.

Healthcare-associated infections (HAIs) are an important, potentially preventable reason to maintain a clean healthcare environment. However, guidelines from Europe and North America do not concur—European guidelines recommend using neutral detergent (followed by chlorine-based disinfection (CBD) if required), whilst North American guidelines recommend using detergent or hospital-grade disinfectant-detergents for routine cleaning or decontamination of noncritical healthcare environmental surfaces. The objective of this study was to compare the effectiveness on rates of HAIs of: (i) disinfectant-detergents versus detergents; and (ii) the active ingredient of many disinfectant-detergents—quaternary ammonium compounds (QAC)—versus CBD.

A rapid review of systematic reviews was conducted using the following search terms: keywords and controlled vocabulary terms for the concepts of “healthcare environmental surfaces” AND (“QAC-based disinfectants” OR “disinfectant-detergents” OR “decontamination”) AND (“environmental contamination” OR “colonization” OR “HAIs”). The search filters included systematic reviews, guidelines, and technology reports. The following databases were searched: The Cochrane Library; PubMed; and health technology assessment and guideline websites for gray literature. Systematic reviews of studies comparing the effects of disinfectant-detergents with detergent, or comparing QAC with CBD, on rates of HAIs in the healthcare environment were included. Reviews on the cleaning or disinfection of body surfaces or disinfection of invasive medical devices were excluded. Quality assessment was not conducted. Data extraction was performed using a pro forma.

The literature search resulted in 356 titles. From ninety-four potentially relevant abstracts, fifty-seven full-texts were evaluated: fifty-one were excluded (eight non-English) and six were included. All review authors cautioned that the evidence was low level, methodologically poor, subject to confounding, and didn't address adverse outcomes. The reviews identified eight relevant primary studies, three of which compared disinfectant-detergents with detergent and found no difference in rates of HAI. Five studies compared QAC with CBD. All five demonstrated that CBD was superior to QAC and reduced Clostridium difficile infection rates in outbreak contexts. Furthermore, QAC may induce sporulation and microbial resistance.

Low-level evidence suggested that: there is no advantage in using disinfectant-detergents for routine cleaning of noncritical surfaces; CBD is superior to QAC-based disinfection in reducing clostridial infections; and QAC agents may induce sporulation or microbial resistance.

As part of a national aging and technology network, AGE-WELL, one work group aims to promote the understanding of potential policy and regulatory hurdles among innovators and decision-makers. This study describes the development of resources to help innovators to navigate policy and regulatory systems to have their technologies adopted.

A policy primer was created that highlights considerations for innovators during the innovation process (from development to implementation). The content of the policy primer was developed by identifying resources through the Canadian Agency for Drugs and Technology in Health Grey Matters search tool, and in consultation with legal and regulatory consultants. By surveying AGE-WELL technology-developing projects (n=15) we characterized the technologies being developed within the network. Survey questions included: intended end-user/purchaser of the technology and past/anticipated facilitators/barriers in their innovation process. The policy primer and survey data were combined to create tailored innovation maps with considerations for each technology being developed within the network. These materials were used to develop a beta website where users can receive information relevant to various innovation stages, as it pertains to their technology. We gained feedback about our materials via surveys and interviews with AGE-WELL technology developers.

The tailored innovation maps and website were seen as helpful resources for understanding policy and regulatory processes required for technology adoption. Technology developers expressed interest in gaining further access to these resources. Innovators desired additional resources about demonstrating value and measuring technology effectiveness.

Resources were developed to help guide technology innovators through policy and regulatory processes; preliminary feedback suggests these were valued by innovators. Next steps include refining the website and releasing these resources to innovators beyond the AGE-WELL Network.

Preference-based measures of health-related quality of life play a key role in the calculation of Quality-Adjusted Life Years (QALYs) for Health Technology Assessment (HTA). The Child Health Utility 9D (CHU9D) is a new preference-based instrument designed specifically for application in children and adolescents (aged 7 to 17 years). This study aimed to compare Chinese and Australian adolescent population preferences for CHU9D health states using profile case best worst scaling (BWS) methods.

Fifty CHU9D health states (blocked into five survey versions) were generated for valuation using a fractional factorial design. Study participants were recruited through an online panel company in Australia, and through primary and secondary schools in China. A latent class modelling framework was adopted for econometric analysis.

A total of 1,982 respondents (51 percent female) in Australia and 902 respondents (43 percent female) in China provided useable survey responses. Latent class analysis indicated the existence of preference heterogeneity for both population groups. In the Australian sample, respondents in Class I placed the most importance on the mental health dimensions of the CHU9D (for example, Worried and Annoyed) and the least importance on daily activities (for example, Activities, Daily routine, Sleep), whilst respondents in Class II placed equal weights on all attributes. In the Chinese sample, respondents in Class I placed the most importance on the Activities dimension of the CHU9D and the least importance on the Annoyed dimension, whist Class II placed the most importance on the Schoolwork dimension and the least importance on Pain.

This study has provided important cross-country insights into the use of profile case BWS methods to elicit health state preferences with young people for application in HTA in children and adolescents. The differential latent classes identified between Australia and China highlights the necessity to derive country-specific adolescent scoring algorithms for the CHU9D instrument for application in HTA.

The Health Technology Assessment International (HTAi) community recognises the importance of including patients’ views from published research and systematically obtaining input from patient organizations (POs). The HTAi's Patients and Public Involvement Subgroup has elaborated the Patient Group Submission Template for HTA (HTA Template) to facilitate the collection of evidence from patients via POs involvement. In 2015 AGENAS outlined a procedure to involve POs and tested the HTA Template within a Health Technology Assessment (HTA) report on dialysis.

The HTAi template was translated into Italian and adapted to the HTA report's specific information needs: to understand patients’ experiences with different dialysis modalities and any delivery problems at the regional level. Some questions were reformulated, others were cut and two different versions of the template were used. One was tailored to POs representatives and the other to individual patients selected with a purposive sampling procedure. We provided the HTA Template to POs appointed by an umbrella organization, Cittadinanzattiva, for their input and to identify other relevant POs to be involved. We identified a list of four associations, based on geographical location and typology of patients. Each POs representative completed the first template and administered the second one to, at least one patient for each five dialysis modalities. AGENAS staff provided support on a cascade basis POs collected and returned all templates.

Researchers performed a thematic analysis of the answers received and this input was introduced in the HTA report within the chapter on Patients Aspects. Patients’ experiences closely corresponded to the ones in our qualitative literature's systematic review. However, PO representatives templates revealed an important problem of equity in access to different dialysis modalities across regions that we highlighted in the HTA report's recommendations.

One of the template's limitations was related to self-administration. In some cases, a lack of familiarity with communicating one's views in writing may have affected the survey's informative power. This pilot also demonstrated the need for a more inclusive involvement procedure, as some important POs were not initially represented by the umbrella organization.

Australians are adjusting to mobile health (mHealth) applications (apps) being used in clinical care. The nature of apps presents unique challenges (e.g. rapid lifecycle) to mHealth regulation. The risks they pose are mainly through the information they provide and how it is used in clinical decision-making. This study explores the international regulation of mHealth apps. It assesses whether the approach used in Australia to regulate apps is consistent with international standards and suitable to address the unique challenges presented by the technology.

A policy analysis was conducted of all nine member jurisdictions of the International Medical Device Regulator's Forum (IMDRF), to determine if their regulatory agencies addressed the IMDRF recommendations relevant to the clinical evaluation of mHealth apps. Case-studies (submission to regulatory agencies) were also selected on varying types of regulated apps (standalone, active implantable, etc.) and assessed relative to the principles in the IMDRF's software as a medical device (SaMD): Clinical evaluation (2017) guidance document.

All included jurisdictions evaluated the effectiveness of mHealth apps, assessing the majority of the key sub-categories recommended by SaMD: Clinical evaluation. The submissions and jurisdictional regulatory bodies did not address the IMDRF safety principles in terms of the apps’ information security (cybersecurity). Furthermore, by failing to use the method recommended by the IMDRF (risk-classification), none of the submissions or jurisdictions recognized the potential dangers of misinformation on patient safety.

None of the approaches used by global regulatory bodies adequately address the unique challenges posed by apps. Australia's approach is consistent with app regulatory procedures used internationally. We recommend that mHealth apps are evaluated for cybersecurity and are also classified using the IMDRF risk-categories so as to fully protect the public.

Despite increased healthcare systems costs, limited opportunities for health economics training are available to healthcare professionals. From 2016-2018, with a grant from the Brazilian Ministry of Health, the Federal University of Goias with 7 other universities, implemented the distance learning Postgraduate Certificate in Health Economics for Health Care Professionals (PCHE) aimed at enhancing technical capacity of professionals working in the Brazilian Public Healthcare System (SUS).

This is a descriptive and qualitative assessment of the PCHE implemented in Brazil 88 healthcare professionals working in SUS and involved in decision making in all levels of managament were enrolled in a health economics training, through long-distance learning strategy. We present course metrics, describe its workload, content, modalities and structure of training.

PCHE was structured with 3-day workshops introducing each of the modules, during which students were also evaluated regarding the previous module content. With a total workload of 360 hours, structured in four modules: Public Health and Epidemiology; Introduction to health economics and healthcare funding; Management of healthcare resources; and Healthcare economic evaluation. The module coordinator was resposible for supervision of course materials development, workshop, distance based tutoring activities, and evaluation. Course material included theorethical content and practical tools for economic evaluation and health technology assessment in the workplace, applying problem-based learning strategies. Certificates were granted to students with 75 percent presence and approved in all modules, and final papers approved by an examination board. Each module was completed in 8 weeks (90 hours/module). Within groups of 20 students, tutors performed communication witn chats twice weekly and discussion forums by topic.. A total of 88 students were enrolled. Drop-out rate was 35.2 percent (n = 31). Additional 10 students did not pass the exams. In total, 47 students completed the training.

Health economics training through distance learning is a more efficient use of resources with good results.

Postoperative delirium has been associated with poorer long term survival in Transcatheter aortic valve replacement (TAVR) and Surgival aortic valve replacement (SAVR) patients. However, its effect on hospitalization costs and length of stay in these populations has not been formally assessed.

Using the Medicare Provider Analysis and Review File, we retrospectively analyzed elderly (80 years of age and older) Medicare patients receiving TAVR and SAVR in the United States during the 2015 fiscal year. ICD-9-CM codes were used to identify postoperative delirium diagnoses. The incremental hospital resource consumption, measured as hospital cost and length of stay, was estimated for patients with postoperative delirium during their TAVR or SAVR index hospitalization. Multivariate regression models were used for the adjusted cost estimates controlling for patient demographics, comorbidities, and complications.

A total of 21,088 claims were available for analysis (12,114 TAVR and 8,974 SAVR). The mean age of the TAVR group was older compared to the SAVR group (87 versus 84; p < .001) and TAVR patients presented with a higher comorbidity burden (Charlson Index score 3.0 versus 2.1; p < .0001). TAVR patients experiencing postoperative delirium during the index hospitalization was 1.6 percent compared to 3.6 percent of surgical patients (p < .0001). For the overall cohort, the regression adjusted incremental cost of postoperative delirium was (USD15,592; p < .0001). Patients experiencing delirium also had significantly longer hospital length of stay (4.16 days; p < .0001). When stratified by treatment approach, the adjusted incremental cost was USD13,862 for TAVR (p < .0001) and USD16,656 for SAVR (p < .0001).

While infrequent, postoperative delirium significantly increased hospital cost and length of stay following transcatheter or surgical aortic valve replacement (AVR). Despite a significantly higher comorbidity burden, TAVR was associated with lower postoperative delirium rates compared to SAVR. Moreover, post-TAVR delirium may be associated with less resource consumption than post-SAVR delirium. Future studies should seek to determine whether general anesthesia avoidance in appropriately selected transfemoral TAVR patients can further decrease rates of delirium.

Mental illnesses are among the most common health problems in children and adolescents worldwide, and their prevalence has recently increased. At the same time, many countries face gaps in care and a shortage of services. To address these challenges, countries are developing child and adolescent mental health (CAMH) strategies and adopting their models of care. This paper aimed to give an international overview of these strategies and care models to support decision makers and stimulate mutual learning and improved CAMH care.

We identified core topics within published CAMH strategies and care model documents from seven selected countries within the Global North, which represented different healthcare systems, geographical regions, and public health traditions to maximize variety. We systematically extracted data on the identified topics and summarized them narratively by applying qualitative content analyses.

The documents addressed the following core topics: awareness raising activities; prevention and promotion; detection; treatment; telemedicine; care pathways; transitional psychiatry; vulnerable patient groups; user participation; infrastructure; workforce development; implementation; digital tools for case management; and data acquisition and research. A stand-alone CAMH strategy exists in most countries.

Recommendations on CAMH care often followed a public mental health approach and placed a high priority on mental health promotion and cross-sectional organization and funding of CAMH care services. Key principles of future CAMH care included: increased flexibility of care settings; early intervention; an open and non-judgmental attitude among staff; and strengths orientation instead of focusing on deficits and diagnoses.

Reducing the prevalence of mental illness and current shortcomings in care requires action at the policy level (e.g., developing a CAMH strategy with a focus on mental health promotion and installing cross-sectoral governance), organizational level (e.g., reorganizing treatment settings and pathways of care), and individual level (e.g., strengthening user involvement and workforce development). Applying the recommended approaches in other countries will likely require redesign, ideally with a participatory approach and evaluation alongside piloting.

Hemodialysis (HD) and peritoneal dialysis (PD) are commonly used to treat patients with end-stage renal disease (ESRD). However, their costs have grown considerably in recent years as the rates of non-communicable diseases including diabetes and hypertension have grown. This will adversely impact on national health budgets especially in low- and middle-income countries (LMICs). Currently, there is limited knowledge about the costs of ESRD and the different components within the public healthcare system in South Africa. Consequently, our objective was to examine the direct medical costs of both approaches from a public provider perspective to provide future guidance.

A prospective observational study undertaken at a leading public hospital in South Africa based principally on patients’ notes and costs from nationally procured lists. A micro-costing approach was used to estimate health care costs among adult patients with ESRD who had received either HD and PD for at least 3 months.

The majority of patients (35 percent) were aged 40 to 50 years. Patients aged 29-39 years were mostly on HD (28 percent) while those between 51-59 years mostly on PD (29 percent), with HD typically managed in the private sector with limited facilities in the public sector. The average age of patients on HD and PD was 41 and 42 years respectively. Variable costs (USD 20, 488.79) were the highest cost component for PD patients with fixed costs the highest component for HD patients ((USD 16,231.45). The annual cost of HD (USD 31,993.12) was higher than PD (USD 25,282 per patient) but not statistically significant (p = 0.816). The overall burden if appreciably more patients with ESRD are managed appropriately within the public system (covering 80 percent of the population) would be considerable and become unaffordable.

HD costs more than PD. These cost estimates are useful for carrying out future health economic analyses and for allocating greater resources to prevent progress to ESRD.

To develop best-practice guidance for health technology assessment (HTA) agencies when appraising diagnostic tests for SARS-CoV-2 and treatments for COVID-19.

We used a policy sandbox approach to develop best-practice guidance for HTA agencies to approach known challenges associated with assessing tests and treatments for COVID-19. The guidance was developed by a multi-stakeholder workshop of twenty-one participants representing HTA agencies, clinical and patient experts, academia, industry, and a payer, from across Europe and North America. The workshop was supported by extensive background work to identify the key challenges, including: targeted reviews of existing COVID-related methods guidance for assessing interventions and clinical guidelines, engagement with clinical experts, a survey and workshop of HTA agencies, a systematic review of published economic evaluations, and a workshop of health economic modelers.

We suggest HTA agencies should consider using other types of evidence (e.g., real world) where high-quality randomized controlled trials may be lacking and healthcare systems would value timely HTA outputs. A “living” HTA approach may be useful, given the context of an evolving disease, scientific understanding and evidence base, allowing for decisions to be efficiently revisited in response to new information; particularly, if supported by a common “disease model” for COVID-19. Innovative ways of engaging with the public and clinicians, and early engagement with regulators and payers, are recommended.

HTA agencies should consider the elements of this guidance that are most suited to their existing processes to enable them to assess the effectiveness and value of interventions for COVID-19.

Evidence development for medical devices is often focused on satisfying regulatory requirements with the result that health professional and payer expectations may not be met, despite considerable investment in clinical trials. Early engagement with payers and health professionals could allow companies to understand these expectations and reflect them in clinical study design, increasing chances of positive coverage determination and adoption into clinical practice.

An example of early engagement through the EXCITE International model using an early technology review (ETR) is described which includes engagement with payers and health professionals to better inform companies to develop data that meet their expectations. ETR is based on an early evidence review, a framework of expectations that guides the process and identified gaps in evidence. The first fourteen ETRs were reviewed for examples of advice to companies that provided additional information from payers and health professionals that was thought likely to impact on downstream outcomes or strategic direction. Given that limitations were imposed by confidentiality, examples were genericized.

Advice through early engagement can inform evidence development that coincides with expectations of payers and health professionals through a structured, objective, evidence-based approach. This could reduce the risk of business-related adverse outcomes such as failure to secure a positive coverage determination and/or acceptance by expert health professionals.

Early engagement with key stakeholders exemplified by the ETR approach offers an alternative to the current approach of focusing on regulatory expectations. This could reduce the time to reimbursement and clinical adoption and benefit patient outcomes and/or health system efficiencies.

Innovative therapies with high cost are increasing in every therapeutic area, making it increasingly difficult the role of the pharmacist in trying to rationalize the economic resources to satisfy the needs of the entire population. The analysis of therapeutic appropriateness has a key role in the management of chronic inflammatory diseases where the biological drugs are used by patients for a long period of time. With increasing competition among companies and the advent of the first biosimilar drugs, the costs are declining and the duty of the Pharmacist is the supervision of treatments so that there is a good cost / effectiveness in an attempt to free resources and safeguard the survival of the Health Service National.

In the year 2015 up to September 2016, all patients were monitored in the departments of Rheumatology, Gastroenterology and Dermatology based on the type of disease, drugs, route of administration and dosages. We evaluated the previous non-biological treatments of first line, therapeutic switch between any drugs with different mechanisms of action, the analysis on the state of the disease, any therapeutic dosages not reported in Summary of Product Characteristics and the reasons that lead the doctors to deviate from guidelines.

The treatments of 684 patients were analyzed: 409 in Rheumatology, 212 in Gastroenterology and 63 in Dermatology. The most frequently used drugs are those that have major use in clinical practice: Adalimumab, Etanercept and Infliximab (three anti-TNF alpha drugs). The first two, having a subcutaneous administration compared to intravenous administration, allow greater patient compliance and are therefore preferred to Infliximab. In Rheumatology the use of newer drugs with different mechanisms of action by inhibition of TNF alpha is not negligible and this is an indication of poor accuracy in the application of the guidelines.

Biologicals are well tolerated and improve the quality of life of people with highly disabling diseases. The therapeutic appropriateness and adherence to guidelines are the only way to try to contain costs. The hope is that, in this new year 2017, new biosimilar drugs are approved that would make, at least for the naïve subjects, more sustainable management of these diseases.

Out of 185 orphan medicinal products (OMPs) registered in 2015–2021, a mere 110 (59 percent) were available to Czech patients, and only 54 (29 percent) were officially reimbursed. Moreover, this proportion has steadily decreased over time. After years of public debate induced by this unsatisfactory OMP patient access, the national viewpoint shifted toward creating a special pathway for the reimbursement of OMP. Thus, a rigorous pricing and reimbursement procedure with strict timelines and elaborated methodology has been recently adopted in Czechia.

The innovative legislation follows the recommendations for value assessment and funding processes for rare diseases and incorporates additional elements of value, such as the societal perspective. First, the application with clinical evidence, cost-effectiveness, and budget impact analyses is submitted to the governmental health technology assessment (HTA) agency by the Marketing Authorization Holder or a Health Insurance Fund. Moreover, professional associations and patients’ organizations are rightful participants in the proceeding, providing evidence and comments. Then, the HTA agency performs the assessment/appraisal of the evidence. It subsequently publishes the assessment report summarizing available information. The report is then forwarded to the Ministry of Health and its advisory body consisting of patients, clinical experts, health insurance funds, and the State. They critically evaluate the documents and issue a binding opinion following prespecified decision-making criteria. Based on this binding opinion, the decision is issued by the HTA agency. Thus, the role of the advisory body in this process is crucial.

We believe that this novel approach may offer satisfactory patient access to orphan drugs. Moreover, it serves as a real-world example of “value-based” decision making.